1. Field of Invention
The present invention is generally related to processes for preparing patients to undergo colonoscopic, endoscopic, or sigmoidoscopic examination, and for treatment. In particular, the present invention relates to the administration to a patient in need of such preparation a salt solution and instructions regarding performing certain maneuvers or exercises, including those known as Shankha Prakshalana, with the intention of cleansing the human bowel in preparation for examination and/or relating to treatment.
2. Description of the Related Art
Colon cancer is cancer of the large intestine (colon), the lower part of the human digestive system. Rectal cancer is cancer of the last six inches of the colon. Together, they are often referred to as colorectal cancers. About 112,000 people are diagnosed with colon cancer annually, and about 41,000 new cases of rectal cancer are diagnosed each year, according to the American Cancer Society.
Colon cancer incidence is not much different between males and females, however colon cancer is slightly more prevalent in women compared to men (ratio of 1.2:1). Rectal cancer is more common in males (ratio of 1.7:1). Colon cancer is more common among elderly persons compared to younger persons. The risk of developing colon cancer begins to increase from the age of 40 and goes up with every passing year. The median age of presentation of colon cancer varies according to the country. In the United States the median age at presentation is 72 years. Colon cancer is more common in African Americans compared to the Caucasian population in the United States. The incidence of colon cancer has been on the increase in African Americans since 1973 and the incidence in this ethnic group has gone up by about 30 percent during the last 3 decades. Incidence of colorectal cancer varies widely from country to country. Countries which are more industrialized like the United States, Canada, UK, Western Europe, and Australia, have a much higher incidence of colorectal cancer compared to less industrialized parts of the world, like Asia, Africa, and South America.
Most cases of colon cancer begin as small, noncancerous (benign) clumps of cells called adenomatous polyps. Over time some of these polyps become colon cancers. Polyps may be small and produce few, if any, symptoms. Regular screening tests can help prevent colon cancer by identifying polyps before they become cancerous. If signs and symptoms of colon cancer do appear, they may include changes in bowel habits, blood in the stool, persistent cramping, gas or abdominal pain. In that event, contemporary medical practice is that the patient undergo colonoscopic examination.
An “endoscopy” is a minimally invasive diagnostic medical procedure that is used to assess the interior surfaces of an organ by inserting a tube into the body. The instrument may have a rigid or flexible tube, and it not only provides an image for visual inspection and photography, but it also enables taking biopsies and retrieval of foreign objects.
A “colonoscopy” is a type of endoscopic examination of the large colon and the distal part of the small bowel using a CCD camera or a fiber optic camera on a flexible tube passed through the anus. It may provide a visual diagnosis (e.g. ulceration, polyps) and grants the opportunity for biopsy or removal of suspected lesions. A “sigmoidoscopy” is a type of colonoscopy that is the minimally invasive medical examination of the large intestine from the rectum through the last part of the colon.
A colonoscopy enables a physician to examine the interior of the entire large intestine, from the lowest part, the rectum, all the way up through the colon to the lower end of the small intestine. The procedure is used to diagnose the causes of unexplained changes in bowel habits. It is also used to look for early signs of cancer in the colon and rectum. Colonoscopy enables the physician to see inflamed tissue, abnormal growths, ulcers, bleeding, and muscle spasms. If anything unusual is in a colon, like a polyp or inflamed tissue, is found, the physician can remove a piece of it using tiny instruments passed through the scope, and then send it for a biopsy examination.
In preparing to undergo a colonoscopic examination, the colon must be free of solid matter for the test to be performed properly. Generally speaking, for one to three days, the patient is required to follow a low fiber or clear fluid-only diet. Examples of clear fluids are apple juice, bouillon, artificially flavored lemon-lime soda or sports drink, and of course water. It is very important that the patient remains hydrated.
Use of solutions to cleanse and irrigate (a.k.a. “bowel preps”) are well known in the prior art. U.S. Pat. No. 6,132,767 provides a history of colonic evacuants, their problems, and various solutions that others have achieved. Currently, various methods are employed to clear and cleanse the bowel in preparation for the colonoscopy. Often, a liquid preparation designed to stimulate bowel movements is given by mouth, which may cause bloating. Other laxative preparations, such as castor oil, may also be used. Additional approaches include special diets or the use of enemas. There are three broad categories, based on pharmacological mechanism of action, of bowel preparations commonly prescribed by physicians: (1) isotonic salt solutions, (2) phosphate or magnesium based solutions, and (3) polyethylene glycol (PEG) based preps.
Historically, bowel prep products required patients to ingest isotonic saline. More recently, the day before the colonoscopy, the patient is either given an osmotic laxative preparation (such as Bisacodyl, phospho soda, sodium picosulfate, or sodium phosphate and/or magnesium citrate) and large quantities of fluid or whole bowel irrigation is performed using a solution of polyethylene glycol (PEG) and electrolytes (e.g. GoLytely, NuLytely). In addition, patients are advised to take additional stool softeners and other medications to assist such as sennakot, docusate sodium, and psyllium based products.
U.S. Pat. No. 6,688,497 teaches a method for preparing a pH balanced saline solution and using the saline solution for rinsing a nasal passage, but does not discuss combining with exercise or treating the bowels. U.S. Pat. No. 5,077,048 discloses using a sodium chloride solution for irrigating the bowels, but does not discuss combining with exercise nor does it teach an isotonic concentration. U.S. Pat. No. 7,332,184 discloses using a sodium chloride solution for irrigating the colon, but does not discuss combining with exercise not does it teach an isotonic concentration.
Thus, while the prior art contains some patents that teach the use of sodium chloride to irrigate body cavities, and specifically the bowel and colon, none of these references teach preparation techniques involving use of exercise or yoga in combination with irrigation solutions to enhance bowel preparation efficacy. Likewise, most of the references also do not indicate the osmolarity or temperature of the specific disclosed solution.
Adequate colon preparation is essential for successful visualization of the colon, and essential for the detection of suspicious lesions. However, studies using large databases of patients reveal that up to 23% of all colonoscopies have suboptimal bowel preparation resulting in longer procedural times, poor intubation rates, and decreased polyp detection. Inadequate preparation may lead to incomplete visualization of the colon, resulting in shortened screening intervals due to concerns about missed lesions.
In addition, the use of PEG based bowel preparations are associated with the following adverse side effects: bloating; nausea; rectal irritation; stomach fullness or cramps; vomiting, and to a lesser extent, allergic reactions (e.g. rash, hives, itching, etc.). Phosphate-based preparations are commonly associated with bloating, nausea, abdominal pain, and vomiting, and to a lesser extent, cardiac arrhythmias, seizures, and renal failure.
Given these side-effects, coupled with the volume and taste of the fluid in the preparations, patients often complain that consuming the preparation is worse than undergoing the colonoscopy. Thus, poor compliance with proper bowel cleansing is often a significant issue with patients presenting for colonoscopy. In fact, inadequate bowel preparation is one of the most common reasons polyps are missed during colonoscopy. Lastly, another restrictive requirement on all contemporary agents used to prepare the bowel for colonoscopy is that those agents must be used or performed on the night before the examination, or at least 12 to 24 hours before.
The medical and overall health benefits of exercise and physical activity have been well documented. The merits of exercise range from preventing chronic health conditions to boosting confidence and self-esteem. Exercise is known to stimulate various brain chemicals, lowers cholesterol and plaque build up in the arteries, improves reuptake of sugar, reduces weight, and promotes better sleep. More importantly, exercise is known to prevent the occurrence and recurrence of colorectal cancer.
Yoga is a group of ancient spiritual practices originating in India. In the medical context, yoga is a simple, non-athletic set of movements and stretches that improve health. Shankha prakshalana is a specific subgroup of Yoga which includes a process to clean the intestinal tract by removing the impurities with salty water and set of exercise positions. For example, the website entitled Yoga Vidya Dham—Yoga Point teaches the performance of the Shankha Prakshalana exercises, and discloses the use of a solution, to clean and cleanse the alimentary tract. Similarly, the website entitled Gandhi Gyan Mandir Yoga Kendra discloses the use of Shankha Prakshalana technique along with a salt solution of 1%. However, neither of those references disclose an isotonic concentration, nor do they discuss the use of the solution and technique for the specific purpose of preparing a patient for colonoscopy, or that the outcome of the Shankha Prakshalana techniques achieves the efficacy necessary for a colonoscopy. Moreover, both websites state that the procedures should be done under direct and strict supervision.
While there is no one uniform approach to Shankha Prakshalana, the ingredients typically used in the solution are limited to salt, water, and lemon juice. Given the simple and natural characteristics of the ingredients, reports of severe adverse reactions in performing Shankha Prakshalana are uncommon. However, nausea, dizziness, bloating, diaphoresis, salt and water retention, general body edema, have been associated with Shankha Prakshalana. Moreover, patients who suffer from hypertension, salt sensitiveness, arthritis, and who are pregnant are contraindicated from performing Shankha Prakshalana.
Given the compliance problems noted above and the need for effective and safe alternative to existing bowel preparation techniques, a better patient preparation method is needed, and one that involves irrigating, clearing and/or cleansing the colon of a patient to such a degree that the patient is available to undergo successful colonoscopy, and one that utilizes natural ingredients and that has a minimal adverse reaction profile, so as to encourage compliance among patients. Lastly, what is needed is an inexpensive and relatively fast method to achieve the cleansing and clearing such that the colonoscopy procedure could be performed on the same day as the preparation procedure.